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NCT01644188 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 720
- Enrollment target
NCT01644188: Completed Phase 3 study, sponsored by Sanofi.
NCT01644188 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 720 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01644188, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 720 participants
- Enrollment target
Study Summary
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia at high cardiovascular (CV) risk. Secondary Objectives: * To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time points * To evaluate the effect of alirocumab on other lipid parameters * To evaluate the safety and tolerability of alirocumab
Primary Outcome
Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment were used in the model (ITT analysis).
Interventions
- DRUG Ezetimibe
- DRUG Alirocumab
- DRUG Placebo (for alirocumab)
- DRUG Placebo (for ezetimibe)
- DRUG Lipid Modifying Therapy (LMT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 720 participants |
| Start Date | 2012-08 |
| Est. Completion | 2015-07 |
| Phase | Phase 3 |
What the finished NCT01644188 record still lists
NCT01644188 is an interventional study that assigns participants to a tested intervention. The registered 720 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Ezetimibe is the first listed.
NCT01644188 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01644188 about?
NCT01644188 is a clinical study titled "Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)". Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tole...
What is the current status of trial NCT01644188?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 720 participants. The study started on 2012-08. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01644188?
The interventions under investigation include: Ezetimibe (DRUG), Alirocumab (DRUG), Placebo (for alirocumab) (DRUG), Placebo (for ezetimibe) (DRUG), Lipid Modifying Therapy (LMT) (DRUG).
Who is sponsoring clinical trial NCT01644188?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01644188's enrollment target sits among peer trials
720 494th of 2000 higher than 1,503 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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